CAR-T Cell Therapy for Desensitization in Kidney Transplantation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06056102
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • End Stage Renal Failure on Dialysis
  • Kidney Failure
  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    * Safety Run-in: 375mg/m\^2 daily x 3 * Cohort 1: 375mg/m\^2 daily x 3 * Cohort 2: 375mg/m\^2 daily x 3 * Cohort 3: 375mg/m\^2 daily x 3
  • CART-BCMA — BIOLOGICAL
    * Safety Run-in: 5 x 10\^7 CAR T cells * Cohort 1: 1.5 x 10\^8 CAR T cells * Cohort 2: 1.5 x 10\^8 CAR T cells * Cohort 3: 5 x 10\^8 CAR T cells
  • huCART19 — BIOLOGICAL
    * Safety Run-in: 5 x 10\^7 CAR T cells * Cohort 1: 1.5 x 10\^8 CAR T cells * Cohort 2: 1.5 x 10\^8 CAR T cells * Cohort 3: 5 x 10\^8 CAR T cells
  • Fludarabine — DRUG
    • Cohort 3: 24mg/m\^2 daily x 3

Study Details

This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.

Key Dates

Start date
May 9, 2024
Status verified
May 2026
Primary completion
Dec 15, 2028
Completion
Dec 15, 2042

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Participant Cohorts
    * Safety Run-in phase (2 subjects at UPenn) * Cohort 1 (3-6 subjects) * Cohort 2 (3-6 subjects) * Cohort 3 (3-6 subjects)

Primary Outcome Measure

The timing of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19) [ Time Frame: 12 months after infusion of CART-BCMA with huCART-19 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital: Transplantation (Site #: 71107)BostonMassachusetts02114
Neelam Nishad
[email protected]
857-867-9797
NYU Langone Health (Site #: 71177)New YorkNew York10016
Kathryn Dzurilla
[email protected]
347-802-5853
University of Pennsylvania Medical Center (Site #: 71111)PhiladelphiaPennsylvania19104
Mary Kaminski
[email protected]
215-349-8334

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital: Transplantation (Site #: 71107)· Boston, MANYU Langone Health (Site #: 71177)· New York, NYUniversity of Pennsylvania Medical Center (Site #: 71111)· Philadelphia, PA

Related Studies